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van CCT (UK)

van CCT (UK)

B-Positive: Enhancing well-being in patients with bipolar disorder

- candidate number28008
- NTR NumberNTR6729
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-okt-2017
- Secondary IDsZonMw 843001803
- Public TitleB-Positive: Enhancing well-being in patients with bipolar disorder
- Scientific TitleB-positive - Effectiveness of a positive psychology intervention for the treatment of euthymic patients with bipolar disorder: a randomized controlled trial
- ACRONYMB-Positive
- hypothesisThe primary hypothesis of the study is that a well-being intervention (‘This is your life’) offered to bipolar disorder (BD) patients in remission in addition to usual care (CAU) is more (cost-)effective than CAU only.
- Healt Condition(s) or Problem(s) studiedBipolar disorder, Recovery
- Inclusion criteriaIn order to be eligible to participate in this study, a subject must meet the following criteria: 1) four or more supportive sessions in the last year and 2) residual depressive symptoms.
- Exclusion criteriaA potential subject who meets any of the following criteria will be excluded from participation in this study: 3) suffer from an acute mood episode or 4) have current addiction problems, and/ or 5) have optimal levels of well-being.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 12-aug-2018
- planned closingdate30-nov-2020
- Target number of participants112
- InterventionsWe aim to adapt the multi-component positive psychology intervention 'This is your life' as a group intervention for BD. The 8-week intervention focuses on six components, including personal strengths, resilience, post-traumatic growth, and positive relationships. The intervention consists of 8 meetings of 2 hours and home exercises.
- Primary outcomeThe primary outcome wellbeing is measured with the Mental Health Continuum – Short Form.
- Secondary outcomeSecondary outcomes include personal recovery (measured with the Questionnaire about the Process of Recovery), relapse (semi-structured telephone interviews), social role participation as part of recovery (Social Role participation Questionnaire), depressive symptoms (Quick - Inventory of Depressive Symptomatology), manic symptoms (Altman Self-Rating Mania Scale), anxiety symptoms (State-Trait Anxiety Inventory), positive emotion regulation (Responses to Positive Affect Questionnaire), positive emotions (Positive and Negative Affect Schedule) and Self-compassion (Self-compassion Scale – Short Form). Economic evaluations are performed using the EQ-5D-5L and the Trimobs and iMTA questionnaire on costs associated with psychiatric illness.
- TimepointsDirectly prior to the start of the intervention a baseline measurement is completed (T0) and four weeks after start of the intervention a mid-treatment measurement is conducted (T1). Directly following the intervention a post measurement will be conducted (T2: approximately three months after baseline). Additionally, two follow-up measurements are conducted, six months (T3) and twelve months after baseline (T4).
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator University of Twente, Dept. of Psychology, Health & Technology (PHT)
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryBipolar disorder (BD) is characterized by recurrent manic or (hypo)manic phases, alternating with (euthymic) states in which patients are relatively symptom free. The prevalence of BD is estimated at 1,3% in the Netherlands. Current treatment for BD in the euthymic phase often focuses on symptomatic and functional recovery, but residual subthreshold depressive symptoms often remain between episodes and form an important risk factor for recurrence. In order to reach full personal recovery, it is important to strive for complete mental health, which encompasses both the absence of mental illness and the presence of well-being. One prominent field focussing on the improvement of well-being, is positive psychology. This is your life is a generic self-help positive psychology intervention developed at the University of Twente, which aims to increase well-being. The current study aims to assess the effectiveness of This is your life adjusted for people with bipolar disorder in the euthymic phase.
- Main changes (audit trail)
- RECORD12-okt-2017 - 31-okt-2018

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